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Vaccines, Blood & Biologics

Review of Chemical Analytical Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Memorandum

Date:
August 10, 2007
To:
Rakesh Pandey Ph.D. OVRR/DVRPA/VVB HFM-478
From:
Alfred V. Del Grosso Ph.D. HFM-406 OVRR/DPQ/PQLS
Nora M. Etz , HFM-406 OVRR/DPQ/PQLS
Through:
Rajesh Gupta, Ph.D. HFM-407 OVRR/DPQ/PQLS
Subject:
CSL Limited Influenza Virus Vaccine (Afluria TM) STN: 125254/0

Review Summary: We have reviewed the following analytical procedures and associated validation studies submitted in the CMC section of this application.

Analytical Procedures:
QA6657 Taurodeoxycholate by -----
QA5030 Thimerosal by --------------------
QA6211 Thimerosal by ------------------------------------
QA5930 pH
QA6699 ------------------------------------------------------------
QA5567 Protein by -----------------------

The following questions should be asked of the manufacturer and commitments should be made prior to licensure:

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3
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